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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Visual Impairment (2138); Meningitis (2389); No Code Available (3191); Hydrocephalus (3272)
Event Date 12/15/2016
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight were unavailable from the attached journal article or by the authors. Patient age and patient sex not made available the attached journal article or by the authors. The article reports that the mean patient age was 59 and the consisted of female patients in the study. Therefore 59 years old and female were used. Event date is approximated. Date provided is when the journal article was accepted. Citation: yano s, hide t, & shinojima n. Efficacy and complications of endoscopic skull base surgery for giant pituitary adenomas. World neurosurg. (2017) 99:533-542. Http://dx. Doi. Org/10. 1016/j. Wneu. 2016. 12. 068. The exact system information could not be determined as it was not provided. However, the system listed on this form was at the address listed in the article during the time some of the surgeries were completed. Device udi not provided as actual product used for this study is unknown. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's surgical navigation system. There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event. Device not returned by customer.
 
Event Description
The journal article was forwarded by medtronic representative. Article indicated the use of surgical navigation system. Objective: we report surgical results and complications of endoscopic endonasal skull base surgery for giant pituitary adenomas. Methods: this study included 34 pituitary adenomas >40 mm treated by endoscopic endonasal skull base surgery between 2002 and 2015. Removal rates, symptoms, and complications were analyzed by direction of tumor extension. Results: average tumor size was 45. 5 mm. Near-total resection was achieved in 16 of 34 (47. 1%) cases. Near-total resection was achieved significantly more often in anterior extension types and round tumor in superior extension types compared with multiple extension types. The average residual amount in 18 partial resection cases was 30. 2% of preoperative volume, with no significant difference between groups. Regrowth after partial resection occurred in 8 cases, but repeated surgery or stereotactic radiotherapy controlled tumor growth and improved symptoms. Postoperative improvement of visual field deficits was achieved in 23 of 25 (92. 0%) cases. Postoperative complications included visual deterioration (n [ 1), cerebrospinal fluid leakage (n [ 2), and cerebral infarction secondary to perforator injury (n [ 2). Symptomatic intratumoral hemorrhage occurred in 1 multiple extension type. Conclusions: endoscopic endonasal skull base surgery enables less invasive and safer removal of various extension types of giant pituitary adenomas. Preservation of visual function is essential. Two-stage surgery or partial resection with additional treatments is possible without complications if a sufficient amount of resection is performed. In cases in which insufficient resection may be expected, alternative treatment, including combined simultaneous resection, should be considered. Reported adverse event : 4 new anterior hormonal deficiency, 7 permanent diabetes insipidus, 2 csf leakage , 2 meningitis , 1 visual deterioration , 2 cerebral infarction , 1 hydrocephalus.
 
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Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
koko tyler
navigation customer quality
826 coal creek circle
louisville, CO 80027
7208903200
MDR Report Key7895829
MDR Text Key120960602
Report Number1723170-2018-04896
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
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